Amongst the data presented, three new studies from the investigational QVA149 IGNITE Phase III clinical trial program (SHINE, ILLUMINATE and ENLIGHTEN) demonstrated that QVA149 significantly improved lung function compared to other COPD therapies1,2,3.

Professor of Respiratory Medicine Wisia Wedzicha, University College London, commented: “The results of the studies with the dual bronchodilator QVA149 show that dual bronchodilatation has an important place in the management of COPD with improvements noted in lung function, management of COPD symptoms and improvements in quality of life.”

About the study results

Data from the IGNITE trial programme demonstrated the efficacy of the dualbronchodilator QVA149 and showed a superior effect on lung function and patientreported outcomes versus comparators1,2,3.

ILLUMINATE compared QVA149 110/50 mcg to the twice-daily LABA/ICS salmeterol/fluticasone 50/500 mcg head-to-head over 26 weeks in patients with COPD 2.The study met its primary endpoint by demonstrating that the mean FEV1 area under the curve (AUC) for 0-12hr at Week 26 was significantly higher with QVA149 compared to salmeterol/fluticasone 50/500 mcg (+140mL; p<0.001)2. Mean FEV1 AUC0-12h was also significantly higher with QVA149 versus salmeterol/fluticasone 50/500 mcg at Day 1 (+70mL; p<0.001)2 and Week 12 (+120mL; p<0.001)2. The ILLUMINATE trial also demonstrated that QVA149, in comparison to salmeterol/fluticasone 50/500 mcg, significantly improved shortness of breath measured by transition dyspnea index or TDI (p=0.003) and reduced reliever medication use (p=0.019) over 26 weeks2.

ENLIGHTEN demonstrated the efficacy of QVA149 at improving lung function over a 52-week period by showing that QVA149 increased FEV1 and forced vital capacity (FVC)versus placebo at Day 1 and Weeks 3, 6, 12, 26, 39 and 52 (p<0.001)3. At Week 52, the mean difference in FEV1 compared to placebo at 60 minutes post-dose was +257mL (p<0.001)3.

QVA149 was generally well tolerated in the SHINE, ILLUMINATE and ENLIGHTEN trials with an incidence of adverse events that was similar between respective groups1,2,3.Data were also presented on two other products from the Novartis COPD portfolio. Data from the GLOW Phase III clinical trial programme demonstrated that the investigational LAMA, glycopyrronium bromide increased lung function and improved patient outcomes compared to placebo4,5. Data from the INERGIZE Phase III/IV pooled analysis showed indacaterol 300 mcg was superior to OL tiotropium 18 mcg in improving shortness of breath6.

Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. Onbrez® Breezhaler® (indacaterol maleate) is a long-acting beta2-adrenergic agonist (LABA) that is currently the only COPD treatment on the market to offer clinically relevant 24-hour bronchodilation combined with a rapid onset of action at first dose, as demonstrated in the INERGIZE Phase III/IV trial program7-10. Onbrez® Breezhaler® is approved in more than 85 countries around the world. It was first launched in the EU (150 mcg and 300 mcg once-daily doses) and has since received approvals in markets worldwide including Japan (Onbrez® Inhalation Capsules 150 mcg once-daily) and US (ArcaptaTM NeohalerTM 75 mcg once-daily).

Glycopyrronium bromide is an investigational LAMA developed as a once-daily inhaled maintenance therapy for the treatment of COPD. Phase III data from the GLOW 1, 2 and 3 studies demonstrated that glycopyrronium increased patients' lung function over a 24-hour period ompared to placebo with a fast onset of action at first dose, and improved exercise endurance versus placebo11-13. Glycopyrronium bromide was licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei. In June 2012, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the approval of glycopyrronium bromide in Europe under the brand name Seebri® Breezhaler®.

QVA149 is an investigational inhaled, once-daily, fixed-dose combination of indacaterol maleate and glycopyrronium bromide. QVA149 is being investigated for the treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE is one of the largest international clinical trial programs in COPD comprising 10 studies in total with more than 7,000 patients across 42 countries1-3,14-20. The first five studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK) have already completed in 2012 with three additional studies (BLAZE, ARISE, BEACON) expected to complete by the end of the year. The studies are designed to investigate efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, shortness of breath and quality of life. Initial filings for regulatory approval are expected in Q4 2012 for Europe and Japan. US filing is expected at the end of 2014.

All Novartis COPD portfolio products are being developed for delivery via the Breezhaler® device, a single-dose dry powder inhaler (SDDPI), which has low air flow resistance, making it suitable for patients with airflow limitation, such as COPD patients. The Breezhaler® device allows patients to hear, feel and see that they have taken the drug correctly18.

About COPD

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating shortness of breath. It affects an estimated 3.7 million people in the UK21 and is predicted to be the third leading cause of death by 202022. Although COPD is often thought of as a disease of the elderly, 50% of patients are estimated to be under the age of 65, which means that half of the COPD population is likely to be affected at the peak of their earning power and family responsibilities23.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2011, the Group’s continuing operations achieved net sales of USD 58.6 billion,while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 126,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.